Job Description

The QC Sr. Associate I, LIMS Support, is responsible for contributing to key functional, tactical, and operational aspects of the QC LIMS group at Biogen. This includes collaborating with members of the QC organization to implement new and revised LabWare LIMS objects. Their primary function is to gather and refine user requirements, communicate requirements to LIMS technical developers, execute verification testing of new/revised LabWare configuration, and to support scheduling/coordination of these activities by other QC LIMS Support team members. This role will also support creation, review and approval of static data within the system. Supports management for activities related to interviewing/training, compliance with policies, providing feedback for personnel development, effective and timely decision making/corrective actions. Success in this role requires proficiency in LIMS configuration, system, and ability to serve as a subject matter expert in this arena. Proficient with interfacing with key stakeholders and customers. Able to work effectively, independently and within a team framework, across all business areas and levels of the organization. This role requires an ability to develop strong relationships with internal and external counterparts, possess effective interpersonal, strong verbal and written communications skills, a collaborative spirit and ability to think outside of the box to influence and drive continuous improvement efforts. This person must be comfortable working in a fast-paced environment with minimal direction and ability to deal with ambiguity and changing priorities. Responsibilities • Collaborate with business subject matter experts to define and document new or revised LabWare requirements. Draft necessary requirement and verification/qualification documentation. Communicate requirements and programming needs to IT and other LabWare technical developers. • Perform configuration of basic and advanced LabWare objects including, but not limited to: Specifications, Analyses, Batch Templates, Calculations, Format Calculations, Code Snippets, Visual Workflows, Queries, and Various Templates (ELN Experiments, ELN Experiment Workbooks, Stability, Sample Login, Standards and Reagents). • Execute qualification or verification testing to support final implementation of LabWare configuration additions/revisions. • Assist the LabWare business owner or QC LIMS Support Team Lead in the prioritization, scheduling, and coordination of LabWare related projects and tasks. • Provide training and day-to-day support to new and existing employees. • Communicate project status, issues, schedule, and accomplishments to various management and stakeholder groups, as needed. Ensures issues/deviations are mitigated appropriately. • Support the identification, definition, and implementation of more efficient processes around LabWare design and change management. Assist in the development of system design standards and best practices. Author SOP and Change Control requests. • Provide technical support during audits/inspections. • Participates in Governance and/or LIMS forums, activities. Accuracy of own data/Impact includes GMP data. Participates at the project/program level across department. • Ensure efficient and effective use of time to support priorities and drive for results. • Perform tasks and makes decision consistent with Biogen and industry cGMP/GLP standards. #LI-SK2

Qualifications

• 5+ years of relevant exp. (M.S. degree) or 7+ years of relevant exp. (B.S. degree); Lead role with leadership experience and aptitude • Experience in QC laboratory, LIMS administration or equivalent related training and experience. • In-depth knowledge of Labware LIMs, ELN, analytical laboratory operations, understanding quality system and directives • Strong communication skills and the ability to collaborate across multiple functional areas of the organization. Some leadership experience is preferred. • This requires excellent written and verbal communication skills. The Sr. Associate I should have a mature leadership approach and understanding of their personal communication style and manage that effectively. • Leadership competencies include: Follow up, Decision Making, Communication, Collaboration and Innovation. • Understanding of impact to project teams and business needs. • Assists in measuring and reporting measurable goals and targets. • Strong organizational skills; ability to multi-task and coordinate multiple activities in parallel. • Demonstrated problem solving skills, instrument/method troubleshooting skills and knowledge of FDA/EMA regulations and compliance. • Accountability for self and QC LIMS support team through delivery of appointed deliverables. • Excellent technical writing skills/presentation skills. Approval of complex reports; leads complex problem solving through facilitation/escalation. • Mentors junior members of team in quality systems, and process improvements. • Knowledge of GMP/GLP regulations and subsequent applications to pharmaceutical drug manufacturing. • Experience in contributing to regulatory inspections preferred.

• B.S degree (science preferred) M.S degree (science preferred) with major course work in Chemistry or Biology

Additional Information All your information will be kept confidential according to EEO guidelines.